(Intravenous/Intravitreal) Date of Origin: 10/17/08 Dates Reviewed: 6/17/2009, 12/22/2009, 03/2010, 06/2010, 09/21/2010, 12/2010, 2/15/2011, 03/2011, 06/2011, 09/2011, 12/2011, 03/2011, 6/19/2012, 09/06/2012, 12/06/2012, 02/07/2013, 03/07/2013, 06/06/2013, 08/01/2013, 09/05/2013, 12/05/2013, 03/25/2014 Prior Auth Available: Post-service edit: The medical necessity criteria were developed by ICORE Healthcare for the purpose of making clinical review determinations for requests for medications commonly used in various diseases. The clinical disciplines of oncology, hematology, rheumatology, neurology, internal medicine, pharmacy and nursing were consulted as part of the criteria development. The development followed an extensive literature search pertaining to established clinical guidelines and accepted prescribing patterns for each individual drug. The indications for the medications are consistent with FDA approved indications, CMS coverage guidelines, National Comprehensive Cancer Network (NCCN) guidelines and/or other published peer reviewed research literature. I. Medication Description: Bevacizumab binds vascular endothelial growth factor (VEGF) and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in-vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused a reduction of microvascular growth and inhibition of metastatic disease progression II. III. Length of Authorization: Coverage is provided for 6 months and may be renewed Review Criteria: Coverage is provided in the following conditions: Carcinoma of the colon or rectum o Patient s disease is metastatic or unresectable or locally advanced; AND o Must be used in combination with chemotherapy regimen which contains intravenous 5-fluorouracil (5FU) OR intravenous irinotecan (Camptosar) OR oral capecitabine (Xeloda) Metastatic carcinoma of the colon or rectum (after progression on first-line Avastin) o Patient s disease has progressed on a first-line bevacizumab-containing regimen; AND o Used in combination with intravenous 5-fluorouracil (5FU)- irinotecan (Camptosar) based regimen, if not used in first line regimen; OR o Used in combination with intravenous 5-fluorouracil (5FU)-oxaliplatin (Eloxatin) based chemotherapy regimen, if not used in first line regimen; OR o Used in combination with oxaliplatin (Eloxatin) and irinotecan(camptosar), if not used in the first line regimen Non-squamous non-small cell lung cancer o Patient s disease must be recurrent or metastatic; AND o Patient s cancer is nonsquamous cell histology; AND o Patient must have no recent history of recent hemoptysis (the presence of blood in sputum); AND o Must be used as part of a 1 st line chemotherapy regimen; AND Page 1 of 14
-ORo -ORo 1. Must be used in combination with with cisplatin- or carboplatin-based regimens; AND 2. Patient must have ECOG performance status 0-1 Must be used as part of a continuation maintenance regimen; AND 1. Avastin must have been included in patient s 1 st line chemotherapy regimen; AND 2. Patient s disease has not progressed (achieved tumor response or stable disease)after 1 st line chemotherapy;and 3. Patient must have ECOG performance status 0-1; AND 4. Must be used as a single agent; OR 5. Must be used in combination with Alimta (pemetrexed) if Avastin was previously used with a first-line pemetrexed/platinum chemotherapy regimen Must be used as part of a 2 nd line chemotherapy regimen; AND 1. Must be used in combination with with platinum-based doublet; AND 2. Patient must have ECOG performance status 0-2; AND 3. Patient s 1 st line therapy regimen must have included either Tarceva (erlotinib) or Xalkori (crizotinib) Cervical Cancer o Patient s disease must be recurrent or metastatic; AND o Must be used as first line therapy in combination with Platinol (cisplatin) or Taxol (paclitaxel) Breast cancer: o Patient must have recurrent or metastatic disease; AND o Patient must be HER2 negative; AND o Must be used in combination with paclitaxel Renal cell carcinoma (First line therapy) o Patient s disease must be relapsed OR unresectable Stage IV; AND o Must be used as first line therapy (patient is treament naïve); AND o Patient s disease has predominant clear cell histology; AND Must be used in combination with Intron-A (interferon alpha -2) -ORo Patient s disease has predominant non- clear cell histology; AND Must be used as a single agent Renal cell carcinoma (Subsequent therapy including 2nd line or greater) o Patient s disease must be relapsed OR unresectable Stage IV; AND o Patient s disease has predominant clear cell histology; AND o Must be used as subsequent single agent therapy; AND o Patient has progressed on previous 1 st line therapy with cytokines (i.e. Proleukin or Intron-A) Primary central nervous system (CNS) cancer - Adult Intracranial Ependymoma o Patient must have progressive disease; AND o Patient s disease cell histology must be Adult Intracranial Ependymoma; AND o Must be used as a single agent; AND o Patient s disease cell histology does NOT include subependymoma and myxopapillary Primary central nervous system (CNS) cancer Anaplastic Gliomas and Glioblastoma Page 2 of 14
o Patient s disease cell histology must be Anaplastic Gliomas OR Glioblastoma; AND o Patient s disease is recurrent or patient requires salvage therapy; AND o Must be used as a single agent; OR o Must be used in combination with irinotecan (Camptosar) OR carmustine (BiCNU) OR lomustine (CeeNU) OR temolozomide (Temodar) Ovarian cancer o Patient s disease must be persistent or have recurrence; AND o Must be used as a single agent Soft tissue Sarcoma - Angiosarcoma o Must be used as a single agent for the treatment of angiosarcoma; Soft tissue Sarcoma - Solitary Fibrous Tumor/Hemangiopericytoma o Must be used in combination with temozolomide (Temodar) for the treatment of solitary fibrous tumor and hemangiopericytoma Uterine Neoplasms Endometrial Carcinoma o Must be used as a single agent; AND o Must be 2 nd line or greater therapy Age related wet macular degeneration (AMD) Diabetic macular edema Diabetic Retinopathy Macular edema following retinal vein occlusion FDA-labeled indication(s) IV. Renewal Criteria: Coverage can be renewed based upon the following criteria: Oncology Indications: o Tumor response with stabilization of disease or decrease in size of tumor or tumor spread; AND o Absence of unacceptable toxicity from the drug; OR Metastatic carcinoma of the colon or rectum (additional renewal opportunity): o Patient s disease has progressed on a first-line bevacizumab-containing regimen; AND o Must be used in combination with intravenous 5-fluorouracil (5FU)- irinotecan (Camptosar) based regimen, if not used in first line regimen; OR o Must be used in combination with intravenous 5-fluorouracil (5FU)-oxaliplatin (Eloxatin) based chemotherapy regimen, if not used in first line regimen; OR o Used in combination with oxaliplatin (Eloxatin) and irinotecan(camptosar), if not used in the first line regimen Non-Oncology Indications: o Patient continues to meet criteria identified in section III; AND Page 3 of 14
o o Disease response; AND Absence of unacceptable toxicity from the drug V. Dosage/Administration: Indication Cancer Indications Ophthalmic indications Dose 10mg/kg every 2 weeks OR 15mg/kg every 3 weeks 1.25mg in each eye every 4 weeks VI. Billing/Code Information: JCode: J9035 Avastin (Genentech) 100mg, 400mg injection: 1 billable unit = 10mg C9257 - (Genentech) 100mg, 400mg injection: 1 billable unit = 0.25mg Max Units (per dose and over time): Oncology indications (J9035): Male: 170 billable units per 21 days Female: 150 billable units per 21 days Ocular indications (C9257): Male/Female: 5 billable units per 28 days per eye Covered Diagnosis: ICD-9 Codes Diagnosis 152.0 Malignant neoplasm of duodenum 152.1 Malignant neoplasm of jejunum 152.2 Malignant neoplasm of ileum 152.8 Malignant neoplasm of other specified sites of small intestine 152.9 Malignant neoplasm of small intestine, unspecified site 153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE 153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON 153.2 MALIGNANT NEOPLASM OF DESCENDING COLON 153.3 MALIGNANT NEOPLASM OF SIGMOID COLON 153.4 MALIGNANT NEOPLASM OF CECUM 153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS 153.6 MALIGNANT NEOPLASM OF ASCENDING COLON 153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE 153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE 153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE 154.0 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION 154.1 MALIGNANT NEOPLASM OF RECTUM 154.8 MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS 158.0 MALIGNANT NEOPLASM OF RETROPERITONEUM Page 4 of 14
158.8 Malignant neoplasm of specified parts of peritoneum 158.9 Malignant neoplasm of peritoneum, unspecified 162.0 Malignant neoplasm of trachea 162.2 Malignant neoplasm of main bronchus 162.3 Malignant neoplasm of upper lobe, bronchus or lung 162.4 Malignant neoplasm of middle lobe, bronchus or lung 162.5 Malignant neoplasm of lower lobe, bronchus or lung 162.8 Malignant neoplasm of other parts of bronchus or lung 162.9 Malignant neoplasm of bronchus or lung, unspecified 171.0 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK 171.2 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF UPPER LIMB 171.3 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF LOWER LIMB 171.4 Malignant neoplasm of connective tissue and other soft tissue of thorax 171.5 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF ABDOMEN 171.6 Malignant neoplasm of connective tissue and other soft tissue of pelvis 171.7 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF TRUNK UNSPECIFIED 171.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CONNECTIVE AND OTHER SOFT TISSUE 171.9 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED 174.0 Malignant neoplasm of nipple and areola of female breast 174.1 Malignant neoplasm of central portion of female breast 174.2 Malignant neoplasm of upper-inner quadrant of female breast 174.3 Malignant neoplasm of lower-inner quadrant of female breast 174.4 Malignant neoplasm of upper-outer quadrant of female breast 174.5 Malignant neoplasm of lower-outer quadrant of female breast 174.6 Malignant neoplasm of axiliary tail of female breast 174.8 Malignant neoplasm of of other specified sites of female breast 174.9 Malignant neoplasm of breast (female), unspecified 175.0 Malignant neoplasm of nipple and areola of male breast 175.9 Malignant neoplasm of other and unspecified sites of male breast 180.0 Malignant neoplasm of endocervix 180.1 Malignant neoplasm of exocervix 180.8 Malignant neoplasm of other specified sites of cervix 180.9 Malignant neoplasm of cervix uteri, unspecified site 182.0 Malignant neoplasm of corpus uteri, except isthmus 183.0 Malignant neoplasm of of ovary 183.2 Malignant neoplasm of of fallopian tube 183.3 Malignant neoplasm of brad ligament of uterus 183.4 Malignant neoplasm of parametrium 183.5 Malignant neoplasm of round ligament of uterus 183.8 Malignant neoplasm of other specified sites of uterine adnexa 183.9 Malignant neoplasm of uterine adnexa, unspecified site 189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS 189.1 MALIGNANT NEOPLASM OF RENAL PELVIS 191.0 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES 191.1 MALIGNANT NEOPLASM OF FRONTAL LOBE Page 5 of 14
191.2 MALIGNANT NEOPLASM OF TEMPORAL LOBE 191.3 MALIGNANT NEOPLASM OF PARIETAL LOBE 191.4 MALIGNANT NEOPLASM OF OCCIPITAL LOBE 191.5 MALIGNANT NEOPLASM OF VENTRICLES 191.6 MALIGNANT NEOPLASM OF CEREBELLUM NOS 191.7 MALIGNANT NEOPLASM OF BRAIN STEM 191.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRAIN 191.9 MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE 192.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM 197.0 Secondary malignant neoplasm of lung 197.6 Secondary malignant neoplasm of retroperitoneum and peritoeneum 197.7 Malignant neoplasm of liver, secondary 237.5 NEOPLASM OF UNCERTAIN BEHAVIOR OF BRAIN AND SPINAL CORD 239.2 NEOPLASM OF UNSPECIFIED NATURE OF BONE SOFT TISSUE AND SKIN 362.01 Background diabetic retinopathy 362.02 Proliferative diabetic retinopathy 362.03 Nonproliferative diabetic retinopathy NOS 362.04 Mild nonproliferative diabetic retinopathy 362.05 Moderate nonproliferative diabetic retinopathy 362.06 Severe nonproliferative diabetic retinopathy 362.07 Diabetic macular edema 362.30 Retinal vascular occlusion, unspecified 362.35 Central retinal vein occlusion 362.36 Venous tributary (branch) occlusion 362.52 Exudative senile macular degeneration 362.53 Cystoid macular degeneration 362.83 Retinal edema V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.11 Personal history of maligant neoplasm of bronchus and lung V10.3 Personal history of malignant neoplasm of breast V10.43 Personal history of malignant neoplasm of ovary V10.52 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF KIDNEY V10.85 Personal history of malignant neoplasm of brain V16.49 Family history of malignant neoplasm of other genital organs VII. Centers for Medicare and Medicaid Services (CMS): Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, 50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan. Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): Jurisdiction(s): 5, 8 NCD/LCD Document (s): L28576 ICD-9 Codes Diagnosis Page 6 of 14
152.0-152.2 MALIGNANT NEOPLASM SMALL INTESTINE 152.8 MALIGNANT NEOPLASM SMALL INTESTINE 152.9 MALIGNANT NEOPLASM SMALL INTESTINE MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT 153.0-154.8 NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS 158.0 MALIGNANT NEOPLASM OF RETROPERITONEUM 158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM 158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED 162.2-162.9 MALIGNANT NEOPLASM OF MAIN BRONCHUS - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF 171.0 171.9 HEAD FACE AND NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE - 174.0-175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE 180.0 180.9 MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVOX UTERI, UNSPECIFIED SITE 183.0 183.9 MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE 189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS 189.1 MALIGNANT NEOPLASM OF RENAL PELVIS 191.0-191.9 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE Jurisdiction(s): 5, 8 NCD/LCD Document (s): L32013 ICD-9 Codes Diagnosis 115.02 HISTOPLASMA CAPSULATUM RETINITIS 115.12 HISTOPLASMA DUBOISII RETINITIS 115.92 HISTOPLASMOSIS RETINITIS UNSPECIFIED 362.02 PROLIFERATIVE DIABETIC RETINOPATHY 362.07 DIABETIC MACULAR EDEMA 362.16 RETINAL NEOVASCULARIZATION NOS 362.35 CENTRAL RETINAL VEIN OCCLUSION 362.36 VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA 362.52 EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA 362.53 CYSTOID MACULAR DEGENERATION OF RETINA 362.83 RETINAL EDEMA 364.42 RUBEOSIS IRIDIS 365.63 GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE Page 7 of 14
Jurisdiction(s): 10(J) NCD/LCD Document (s): L30555 ICD-9 Codes Diagnosis 115.92 HISTOPLASMOSIS RETINITIS UNSPECIFIED 362.02 PROLIFERATIVE DIABETIC RETINOPATHY 362.06 SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY 362.07 DIABETIC MACULAR EDEMA 362.16 RETINAL NEOVASCULARIZATION NOS 362.35 CENTRAL RETINAL VEIN OCCLUSION 362.36 VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA 362.52 EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA 362.53 CYSTOID MACULAR DEGENERATION OF RETINA 363.43 ANGIOID STREAKS OF CHOROID 365.63 GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE Jurisdiction(s): 10(J) ICD-9 Codes 153.0-153.9 NCD/LCD Document (s): A48896 Diagnosis MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT 154.0-154.8 NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS 162.0-162.9 MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED 174.0-174.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE - MALIGNANT NEOPLASM OF (FEMALE) UNSPECIFIED SITE MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE - 175.0-175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE 183.0 MALIGNANT NEOPLASM OF OVARY 183.2-183.5 MALIGNANT NEOPLASM OF FALLOPIAN TUBE - MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS 183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA 183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE 189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS 189.1 MALIGNANT NEOPLASM OF RENAL PELVIS 191.0-191.9 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE V10.00 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF UNSPECIFIED SITE IN GASTROINTESTINAL TRACT Page 8 of 14
V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.06 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RECTUM RECTOSIGMOID JUNCTION AND ANUS V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF Jurisdiction(s): F NCD/LCD Document (s): A51786 ICD-9 Codes Diagnosis 115.02 HISTOPLASMA CAPSULATUM RETINITIS 115.12 HISTOPLASMA DUBOISII RETINITIS 115.92 HISTOPLASMOSIS RETINITIS UNSPECIFIED 360.21 PROGRESSIVE HIGH (DEGENERATIVE) MYOPIA 362.01 BACKGROUND DIABETIC RETINOPATHY 362.02 PROLIFERATIVE DIABETIC RETINOPATHY 362.03 NONPROLIFERATIVE DIABETIC RETINOPATHY NOS 362.04 MILD NONPROLIFERATIVE DIABETIC RETINOPATHY 362.05 MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY 362.06 SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY 362.07 DIABETIC MACULAR EDEMA 362.15 RETINAL TELANGIECTASIA 362.16 RETINAL NEOVASCULARIZATION NOS 362.29 OTHER NONDIABETIC PROLIFERATIVE RETINOPATHY 362.30 RETINAL VASCULAR OCCLUSION UNSPECIFIED 362.35 CENTRAL RETINAL VEIN OCCLUSION 362.36 VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA 362.52 EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA 362.53 CYSTOID MACULAR DEGENERATION OF RETINA 362.83 RETINAL EDEMA 362.84 RETINAL ISCHEMIA 364.42 RUBEOSIS IRIDIS 365.63 GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE 365.89 OTHER SPECIFIED GLAUCOMA Jurisdiction(s): 6, K NCD/LCD Document (s): A46095 ICD-9 Codes Diagnosis 153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE 153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON 153.2 MALIGNANT NEOPLASM OF DESCENDING COLON 153.3 MALIGNANT NEOPLASM OF SIGMOID COLON 153.4 MALIGNANT NEOPLASM OF CECUM 153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS Page 9 of 14
153.6 MALIGNANT NEOPLASM OF ASCENDING COLON 153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE 153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE 153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE 154.0 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION 154.1 MALIGNANT NEOPLASM OF RECTUM 154.8 MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS 158.0 MALIGNANT NEOPLASM OF RETROPERITONEUM 158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM 158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED 162.0 MALIGNANT NEOPLASM OF TRACHEA 162.2 MALIGNANT NEOPLASM OF MAIN BRONCHUS 162.3 MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG 162.4 MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG 162.5 MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG 162.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG 162.9 MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED 171.0 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK 171.2 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF UPPER LIMB INCLUDING SHOULDER 171.3 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF LOWER LIMB INCLUDING HIP 171.5 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF ABDOMEN 171.7 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF TRUNK UNSPECIFIED 171.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CONNECTIVE AND OTHER SOFT TISSUE 171.9 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED 174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE 174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE 174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE 174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE 174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE Page 10 of 14
174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE 174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE 174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE 174.9 MALIGNANT NEOPLASM OF (FEMALE) UNSPECIFIED SITE 175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE 175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE 183.0 MALIGNANT NEOPLASM OF OVARY 183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE 183.3 MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS 183.4 MALIGNANT NEOPLASM OF PARAMETRIUM 183.5 MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS 183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA 183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE 189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS 189.1 MALIGNANT NEOPLASM OF RENAL PELVIS 191.0 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES 191.1 MALIGNANT NEOPLASM OF FRONTAL LOBE 191.2 MALIGNANT NEOPLASM OF TEMPORAL LOBE 191.3 MALIGNANT NEOPLASM OF PARIETAL LOBE 191.4 MALIGNANT NEOPLASM OF OCCIPITAL LOBE 191.5 MALIGNANT NEOPLASM OF VENTRICLES 191.6 MALIGNANT NEOPLASM OF CEREBELLUM NOS 191.7 MALIGNANT NEOPLASM OF BRAIN STEM 191.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRAIN 191.9 MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE 192.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM 237.5 NEOPLASM OF UNCERTAIN BEHAVIOR OF BRAIN AND SPINAL CORD 239.2 NEOPLASM OF UNSPECIFIED NATURE OF BONE SOFT TISSUE AND SKIN 362.02 PROLIFERATIVE DIABETIC RETINOPATHY 362.07 DIABETIC MACULAR EDEMA 362.16 RETINAL NEOVASCULARIZATION NOS 362.35 CENTRAL RETINAL VEIN OCCLUSION 362.36 VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA 362.52 EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA Page 11 of 14
362.53 CYSTOID MACULAR DEGENERATION OF RETINA 362.83 RETINAL EDEMA 364.42 RUBEOSIS IRIDIS 365.63 GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.06 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RECTUM RECTOSIGMOID JUNCTION AND ANUS V10.11 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BRONCHUS AND LUNG V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF V10.52 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF KIDNEY V10.53 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RENAL PELVIS Jurisdiction(s): 9(N) NCD/LCD Document (s): L29959, L29961 ICD-9 Codes Diagnosis 362.02 PROLIFERATIVE DIABETIC RETINOPATHY 362.07 DIABETIC MACULAR EDEMA 362.16 RETINAL NEOVASCULARIZATION NOS 362.29 OTHER NONDIABETIC PROLIFERATIVE RETINOPATHY 362.35 CENTRAL RETINAL VEIN OCCLUSION 362.36 VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA 362.52 EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA 362.53 CYSTOID MACULAR DEGENERATION OF RETINA 362.83 RETINAL EDEMA 364.42 RUBEOSIS IRIDIS 365.63 GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE VIII. Criteria Exclusions: o Treatment for diagnoses not FDA approved o All indications not described in Section III Review criteria are not covered and may be considered experimental or investigational. IX. Black Box Warnings/Contraindications: Black Box Warnings: o Gastrointestincal perforation o Surgery and wound healing complications o Hemorrhage Contraindications N/A Page 12 of 14
X. References: 1. Avastin [package insert]. South San Francisco, CA; Genentech; March 2013. Accessed March 2014. 2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium ) bevacizumab. National Comprehensive Cancer Network, 2014. The NCCN Compendium is a derivative work of the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2014. 3. American Academy of Ophthalmology Retina/Vitreous Panel. Age-related macular degeneration. San Francisco (CA): American Academy of Ophthalmology (AAO); 2008. 37 p. 4. Intravitreal bevacizumab (Avastin ) treatment of macular edema in central retinal vein occlusion: a shortterm study. Retina. 2006 Mar; 26(3): 279-84 5. Epstein DL, Algvere PV, von Wendt G, et al: Bevacizumab for macular edema in central retinal vein occlusion: a prospective, randomized, double-masked clinical study. Ophthalmology 2012; 119(6):1184-1189. 6. Cekic O, Cakir M, Yazici AT, et al: A comparison of three different intravitreal treatment modalities of macular edema due to branch retinal vein occlusion. Curr Eye Res 2010; 35(10):925-929. 7. Moradian S, Ahmadieh H, Malihi M, et al. Intravitreal bevacizuab in active progressive proliferative diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol 2008;246:1699-1705. 8. Short-term safety and efficacy of intravitreal bevacizumab (Avastin ) for neovascular age-related macular degeneration. Retina. 2006 May-Jun; 26(5): 495-511 9. Rich RM, Rosenfeld PJ, Puliafito CA, et al. Short-term safety and efficacy of intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Retina 2006;26:495-511. 10. Avery RL, Pieramici DJ, Rabena MD, et al. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmol 2006;113:363-72. 11. Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD) for Chemotherapy Drugs and their Adjuncts (L28576). Centers for Medicare & Medicaid Services, Inc. Updated on 02/19/2014 with effective date 03/01/2014. Accessed March 2014. 12. Wisconsin Physicians Service Insurance Corporation Coverage Determinations (LCD) for bevacizumab (L32013). Centers for Medicare & Medicaid Services. Updated on 10/22/2013 with effective date 11/15/2013. Accessed March 2014. 13. Cahaba Government Benefit Administrators, LLC Local Coverage Determinations (LCD) for bevacizumab (L30555). Centers for Medicare & Medicaid Services. Updated on 08/29/2013 with effective date 8/10/2012. Accessed March 2014. 14. Cahaba Government Benefit Administrators, LLC. Local Coverage Article for Drugs and Biologicals - Chemotherapeutic Agents (A48896). Centers for Medicare & Medicaid Services, Inc. Updated on 10/25/2013 with effective date 11/01/2013. Accessed February 2014. 15. Noridian Administrative Services, LLC Articles for bevacizumab (A51786). Centers for Medicare & Medicaid Services. Updated on 10/31/2013 with effective date 11/01/2013. Accessed March 2014. 16. National Government Services, Inc. Local Coverage Article for BEVACIZUMAB (e.g., Avastin ) - Related to LCD L25820 (A46095). Centers for Medicare & Medicaid Services, Inc. Updated on 10/23/2013 with effective date 11/01/2013. Accessed March 2014. 17. First Coast Service Options, Inc. Local Coverage Determination (LCD) for Intravitreal BEVACIZUMAB (Avastin ) (L29959; L29961). Centers for Medicare & Medicaid Services. Updated on 06/15/2011 with effective date 06/14/2011. Accessed March 2014. XI. Appendix: Page 13 of 14
Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor E CA,HI, NV, AS, GU, CNMI Noridian Administrative Services (NAS) F AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Administrative Services (NAS) 5 KS, NE, IA, MO Wisconsin Physicians Service (WPS) 6 MN, WI, IL National Government Services (NGS) H LA, AR, MS, TX, OK, CO, NM Novitas Solutions 8 MI, IN Wisconsin Physicians Service (WPS) 9 (N) FL, PR, VI First Coast Service Options 10 (J) TN, GA, AL Cahaba Government Benefit Administrators 11 (M) NC, SC, VA, WV Palmetto GBA 12 (L) DE, MD, PA, NJ, DC Novitas Solutions K NY, CT, MA, RI, VT, ME, NH National Government Services (NGS) 15 KY, OH CGS Administrators, LLC Page 14 of 14